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Completed

NCT Number: NCT03569618

Digital Cognition in Multiple Sclerosis

A DIGITAL THERAPEUTIC TO IMPROVE THINKING IN MULTIPLE SCLEROSIS

WHO: 65 participants with a confirmed diagnosis of Multiple Sclerosis (MS)

WHY: Purpose of the study is to compare the effect of 2 tablet-based brain training digital tools on important components of thinking (cognition).

WHAT: Complete a set of tests (physical and cognitive) at baseline, 6 weeks and 14 weeks, and use one of two brain training tools on an iPad in your home, for 25 minutes a day, 5 days a week, for 6 weeks.

WHERE: UCSF WEILL INSTITUTE FOR NEUROSCIENCES (675 Nelson Rising Lane, San Francisco, CA)

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Decline Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

About this study

The purpose of this study is to begin to test a brain training video game in people with Multiple Sclerosis (MS).

Visit 1. After informed consent, you will complete a series of questions about your functioning and mood. You will then complete a series of tests (vision, hand tapping, walking). Then, you will complete a set of thinking tests. The first set will be paper and pencil. The second set will be on a tablet or a computer. You will use your study code to sign into these tools and you won't provide any personal details for the digitized tests.

Finally, you will complete the "cognitive training tool". There are two versions of this digital, iPad based tool, which takes about 25 minutes to complete and is designed to be entertaining. You will be randomized into 1 of 2 groups: each group will play a version of the brain training game. You will not be told what group/game type you were randomized into. You will be given the tablet with the game on it to take home, and to practice this game 5 times a week for 6 weeks.

Visit 2. After the 6 weeks of at-home training, you will then come back to the research study unit to do a repeat of the initial visit (with physical and cognitive assessments). At this study visit, you will also be returning the iPad.

Visit 3. You will then return 8 weeks after Visit 2, to do a repeat of the assessments.

You will be compensated for each study visit (visit 1: $50, visit 2: $100, visit 3: $150).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult men or women diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS)
  • SDMT z-score range (-2 to +1)
  • Wifi available in home
  • Able to use a tablet (iPad)
  • Able to attend 3 study visits in person.

Exclusion criteria

  • Clinician's assessment of visual, cognitive, or motor impairment that would preclude participation.
  • A clinical relapse within the last 30 days.
  • Steroid treatment for clinical relapse within the last 30 days.

Treatment and study plan

Tablet-based Game

Device

Tablet-based game aimed at improving processing speed and attention.

Primary outcomes

  1. Change in Processing Speed After 6 Weeks of Treatment With a Digital Therapeutic 'Game 1', vs. 'Game 2'.

    Time frame: Baseline and 6 weeks

    Processing speed is being measured by the Symbol Digit Modalities Test (SDMT) score. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.

Secondary outcomes

  1. Number of Participants With at Least 4-point Increase in SDMT Above Their Baseline Value 8 Weeks After Treatment

    Time frame: 14 weeks

    Number of participants showing a clinically meaningful 4+ point increase in SDMT (symbol digit modalities test) relative to baseline SDMT score. Comparison of SDMT changes 8 weeks after end of treatment with Tool 1 vs. Tool 2.

Other outcomes

  1. Change in Mood After 6 Weeks Treatment With Game 1 vs. Game 2

    Time frame: Baseline and 6 weeks

    Comparison of changes in mood (depression, anxiety). Depression measured using the Center for Epidemiologic Studies Depression Scale (CES-D). Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology. Anxiety measured using the State-Trait Anxiety Inventory - State subtest (STAI-S) and the State-Trait Anxiety Inventory - Trait subtest (STAI-T). Both have 20 questions and a score range 20-80, with higher scores indicating greater anxiety.

  2. Change in Fatigue After 6 Weeks Treatment With Game 1 vs. Game 2.

    Time frame: Baseline and 6 weeks

    Fatigue is being measured by the Modified Fatigue Impact Scale (MFIS) which has participants rank 21 items on 1 to 4 (never to always) scale. The score is the sum of these subscales. (max=84, min=0) Lower scores indicate improvement. Higher scores indicate worsening.

  3. Change in a Digital Cognitive Battery After 6 Weeks Treatment With Game 1 vs. Game 2.

    Time frame: Baseline and 6 weeks

    Comparison of changes in scores on Match, a tablet-based assessment of processing speed and executive function. Performance is gauged on a continuous scale using the total number of correct responses given in 2-minutes. The minimum possible score is 0 (no correct responses) with higher scores indicating better performance (no maximum possible score).

  4. Change in Paper and Pencil Cognitive Testing After 6 Weeks Treatment With Game 1 vs. Game 2.

    Time frame: Baseline and 6 weeks

    Comparison of changes in cognition, as assessed using the BICAMS battery (Brief International Cognitive Assessment for Multiple Sclerosis) and PASAT (Paced Auditory Serial Addition Test). The BICAMS battery is composed of 3 tests (for all, higher scores indicate better performance): (1) The Symbol Digit Modalities Test (SDMT), a measure of information processing speed where performance is gauged by the number of correct responses given in 90-seconds, with a minimum possible score of 0 and maximum of 110. (2) The California Verbal Learning Test-II (CVLT-II) is a 5-trial auditory/verbal learning test with a total min. score of 0 and max of 80. (3) The Brief Visuospatial Memory Test -- Revised (BVMT-R) is a visual and spatial memory test given in 3 trials with a total min score of 0 and max of 36.

    The PASAT is a test of information processing and attention with a minimum score of 0 and maximum of 60. Higher scores indicate better performance.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Akili Interactive Labs, Inc.

Registry information

Official study title

Effect of a Digital Therapeutic on Processing Speed in Adults With Multiple Sclerosis

Acronym: DigCog

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 26, 2018
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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